LICENSING
Leuven, Belgium, September 30, 2010 – ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, cardiovascular disease and cancer, announces that it has signed a 10-year supply agreement with MSD Biologics (UK) Ltd, part of the Merck BioManufacturing Network, for the production of microplasmin. ThromboGenics anticipates that this deal will meet its long-term commercial needs for bulk drug substance of this novel therapeutic agent.
Microplasmin, which is ThromboGenics’ lead drug candidate, recently completed two successful Phase III clinical trials in patients with vitreomacular adhesion (VMA). These Phase III results demonstrated microplasmin’s potential to transform the treatment of retinal disorders. ThromboGenics is targeting BLA submission to FDA and MAA to EMA by mid 2011.
MSD Biologics, a contract manufacturing organization with specific expertise in microbialderived biologics, has been producing microplasmin for ThromboGenics since 2007, and provided the clinical bulk substance for ThromboGenics’ extensive Phase III program that recruited over 650 patients in the U.S. and Europe. MSD Biologics will produce microplasmin at its Billingham facility (UK), which has been approved for commercial production by the U.S. FDA and the EMA.
Microplasmin is a truncated form of the natural human protein plasmin. ThromboGenics has created, on a proprietary basis, the first stabilized and readily manufactured form of this molecule.
Steve Bagshaw, Site General Manager, MSD Biologics, added, “We are delighted that ThromboGenics has chosen to continue to work with MSD through this long term supply agreement for the production of microplasmin. We look forward to extending our successful working relationship with them as they progress through the next stage of commercialization plans.”
| ThromboGenics | |
| Dr. Patrik De Haes, CEO | Tel: + 32 16 75 13 10 patrik.dehaes@thrombogenics.com |
| Stuart Laermer, Chief Business Officer | Tel: +1 (212) 201-0920 stuart.laermer@thrombogenics.com |
| Citigate Dewe Rogerson | |
| Tel: +44 (0) 207 638 95 71 amber.bielecka@citigatedr.co.uk | |
| Merck BioManufacturing Network | |
| Bridget Hall, MSD Biologics (UK) Ltd | Tel : +44 (0)1642 367320 bridget.hall@merck.com |
ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company’s lead product microplasmin has completed two Phase III clinical trials for the non-surgical treatment of retinal disorders. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (anti-Factor VIII), a long acting anti-coagulant in Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for cancer in partnership with Roche.
ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at www.thrombogenics.com.
Merck BioManufacturing Network (known outside the USA and Canada as MSD BioManufacturing Network) is a full service CMO providing development and manufacturing services for biologics to pharmaceutical and biotechnology companies. It comprises the operations at Billingham, UK (formerly Avecia Biologics), and at Research Triangle Park, NC, USA (formerly Diosynth Biotechnology). Merck is known as MSD outside USA and Canada. For additional information about Merck BioManufacturing Network, please visit www.biomanufacturingnetwork.com.
Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report.
At Merck, flexibility, innovation and creativity are at the heart of the way we work with partners around the world.
Our Licensing team works with partners to advance their science through drug discovery and development collaborations and licensing agreements that are mutually beneficial.
Our Commercial Partnerships team pursues business opportunities with partners to jointly deliver their products and ours to the marketplace.